Quality Assurance Manager, Contract Manufacturers

Job Summary:

The Quality Assurance Manager, Contract Manufacturers (CMOs) oversees all quality-related activities for external manufacturing partners producing OTC semisolid drug products. This includes compliance with FDA 21 CFR Part 210/211, CHPA guidelines, ICH Q7/Q9/Q10, supplier quality expectations, and internal QMS requirements.

Reporting to:     Director, Quality Services
Location:  Johnson City, TN - onsite

Responsibilities/Essential Duties:

• Provide quality oversight of CMOs producing OTC semisolid products.
• Develop and maintain Quality Agreements.
• Plan and execute GMP audits; support regulatory inspections.
• Review batch documentation, deviations, and OOS/OOT investigations.
• Provide technical QA oversight for semisolid manufacturing processes.
• Oversee complaint investigations, CAPA management, and effectiveness checks.
• Evaluate and approve change controls from CMOs.
• Oversee stability program execution and data review.
• Manage supplier and material quality, including qualification, requalification, and specification control.
• Ensure supplier notifications, investigations, and raw material issues are managed per GMP.
• Support continuous improvement and QMS enhancements.
• Office-based with travel to CMOs and supplier sites.
• Ability to wear PPE as required.

 

Basic Qualifications:

• Bachelor’s degree & 5+ years’ directly related experience.

 

Preferred Qualifications:

• Bachelor’s degree in scientific or engineering field.
• 5-10 years’ QA experience in pharmaceuticals, OTC, or semisolid manufacturing.
• Experience managing CMOs and suppliers.
• Knowledge of FDA 21 CFR 210/211 and ICH Q guidelines.
• Technical expertise in semisolid manufacturing quality standards.
• Strong auditing and communication skills.
• Proficiency with electronic QMS platforms.

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.